Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier:
NCT00278525
First received: January 15, 2006
Last updated: March 28, 2014
Last verified: March 2014
Results First Received: April 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: SYSTEMIC SCLERODERMA
Interventions: Drug: standard of care
Procedure: stem cell transplantation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Eligible (n=19) Randomized (n=19)

  1. Allocated to Hematopoietic Stem Cell Transplantation (HSCT (n=10) + crossed over to HSCT(n=7)

    • Received HSCT (n=17); Lost to follow-up (n=0); Analysed (n=17)

  2. Allocated to cyclophosphamide (n=9) • Received allocated intervention (n=9) Lost to follow-up (n=0); Crossed over (n=7); Analysed (n=9)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
Standard of Care Cyclophosphamide will be given as approved immunosuppressive therapy
Stem Cell Trasplantation intervention as stem cell transplantation after conditioning regimen

Participant Flow:   Overall Study
    Standard of Care     Stem Cell Trasplantation  
STARTED     9     10  
COMPLETED     9 [1]   10 [2]
NOT COMPLETED     0     0  
[1] 7 participants crossed to HSCT arm in accordance with the protocol
[2] 7 participant crossed over to the HSCT arm and underwent HSCT, in accordance with the protocol.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Stem Cell Trasplantation intervention as stem cell transplantation after conditioning regimen
Standard of Care medication as standard of care will be given
Total Total of all reporting groups

Baseline Measures
    Stem Cell Trasplantation     Standard of Care     Total  
Number of Participants  
[units: participants]
  10     9     19  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     9     19  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 13     44  ± 10     44  ± 10  
Gender  
[units: participants]
     
Female     10     8     18  
Male     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     10     9     19  



  Outcome Measures
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1.  Primary:   Time to Treatment Failure   [ Time Frame: 12 months ]

2.  Primary:   Disease Improvement   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Richard Burt
Organization: Northwestern University
phone: 312-908-0059
e-mail: rburt@northwestern.edu


No publications provided by Northwestern University

Publications automatically indexed to this study:

Responsible Party: Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00278525     History of Changes
Other Study ID Numbers: DI Scl.Randomized2004
Study First Received: January 15, 2006
Results First Received: April 9, 2013
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration